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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA014699 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Behavioral Health Services, Inc. | INDUSTRY |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The investigators will investigate whether group Cognitive Behavioral Therapy (CBT) for depression, with alcohol and other drug (AOD) treatment counselors leading the groups, is effective and cost effective in treating depression. If so, it could substantially increase access to appropriate mental health care. 360 clients with Beck Depression Inventory-II scores > 17 who are being treated in a single public sector AOD treatment organization will receive one of two conditions: (1) usual care residential AOD treatment (UC); (2) usual care AOD residential treatment plus a 16-session course of group CBT delivered by trained AOD counselors (CBT). Data will be analyzed using an intent-to-treat model. The investigators will collect data on the service-level costs and health effects associated with UC and CBT, and will calculate the incremental cost per unit of depression and AOD improvement, compared to UC.
Individuals with alcohol and other drug (AOD) disorders frequently suffer from depression, leading to reduced quality of life and poorer AOD treatment outcomes. Efficacious treatments for depression do exist and could improve outcomes; but national data suggest that fewer than 7% of people with co-occurring disorders who are in AOD treatment have received appropriate treatment. Group cognitive behavioral therapy (CBT) is an effective and inexpensive treatment for depression. We propose to investigate whether group CBT for depression, with AOD counselors leading the groups, is effective and cost effective in treating depression. If so, it could substantially increase access to appropriate mental health care.
We propose a 5-year quasi-experimental study with the following specific aims: Aim 1. To evaluate the effectiveness of group CBT for depression provided by AOD counselors in improving depressive symptoms and AOD outcomes, among clients being treated in public sector residential AOD treatment settings; Aim 2. To evaluate the cost-effectiveness of group CBT conducted by trained AOD counselors compared to usual care AOD treatment; Aim 3. To document the implementation of the intervention at each of the four sites, and to determine whether the AOD counselors are delivering the group CBT intervention with fidelity to the model, and whether treatment fidelity is a significant predictor of client outcomes.
We will enroll and follow 360 clients with Beck Depression Inventory-II (BDI-II) scores > 17 who are being treated in a single public sector AOD treatment organization at four residential sites in LA County. Subjects will receive one of two conditions: (1) usual care residential AOD treatment (UC); (2) usual care AOD residential treatment plus a 16-session course of group CBT delivered by trained AOD counselors (CBT). Subjects will complete: (1) a baseline interview; (2) a post-treatment interview (at the conclusion of the CBT treatment) and (3) a follow-up interview (3 months after CBT treatment ends). Data will be analyzed using an intent-to-treat model. We will collect data on the service-level costs and health effects associated with UC and CBT, and will calculate the incremental cost per unit of depression and AOD improvement, compared to UC. . The implementation analysis will involve two related sets of activities: (1) a series of key informant interviews to provide a context in which to understand intervention implementation and (2) an assessment of treatment fidelity and it's relationship to client outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group CBT | Experimental | Clients received up to 16 sessions of group CBT for depression |
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| Comparison | Active Comparator | Treatment as Usual comparison condition |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group Cognitive Behavioral Therapy | Behavioral | 16 two hour sessions of group CBT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Depressive Symptoms as Measured by the Beck Depression Inventory II | The Beck Depression Inventory II (BDI-II) is a 21 question, self-administered measure of depressive symptoms. Scores range from 0 - 63, with higher scores indicating more severe depressive symptoms. | 3 Months Post Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Mental Health Functioning as Measured by SF-12 MCS. | The SF-12 is a 12 question, self-administered measure of general health functioning. The SF-12 outputs a mental health summary score (MCS), which ranges from 0 to 100, with higher scores indicating better mental health functioning. MCS scores are standardized such that mean = 50 and SD = 10 in the general U.S. population. | 3 Months Post Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Watkins, MD, MSHS | RAND | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Behavioral Health Services, Inc | Gardena | California | 90249 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22638007 | Derived | Watkins KE, Hunter S, Hepner K, Paddock S, Zhou A, de la Cruz E. Group cognitive-behavioral therapy for clients with major depression in residential substance abuse treatment. Psychiatr Serv. 2012 Jun;63(6):608-11. doi: 10.1176/appi.ps.201100201. | |
| 22564202 | Derived | Hunter SB, Witkiewitz K, Watkins KE, Paddock SM, Hepner KA. The moderating effects of group cognitive-behavioral therapy for depression among substance users. Psychol Addict Behav. 2012 Dec;26(4):906-16. doi: 10.1037/a0028158. Epub 2012 May 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group CBT | Clients received up to 16 sessions of group CBT for depression |
| FG001 | Comparison | Treatment as Usual comparison condition |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group CBT | Clients received up to 16 sessions of group CBT for depression |
| BG001 | Comparison | Treatment as Usual comparison condition |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Depressive Symptoms as Measured by the Beck Depression Inventory II | The Beck Depression Inventory II (BDI-II) is a 21 question, self-administered measure of depressive symptoms. Scores range from 0 - 63, with higher scores indicating more severe depressive symptoms. | Posted | Mean | Standard Deviation | BDI-II score | 3 Months Post Treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group CBT | Clients received up to 16 sessions of group CBT for depression |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Watkins | RAND Corporation | (310) 393-0411 | 6509 | kwatkins@rand.org |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Group CBT for Depression | Behavioral | 16 of group CBT for depression delivered in 2 hour groups for up to 8 weeks by a trained substance abuse treatment counselor |
|
| 21646576 | Derived | Watkins KE, Hunter SB, Hepner KA, Paddock SM, de la Cruz E, Zhou AJ, Gilmore J. An effectiveness trial of group cognitive behavioral therapy for patients with persistent depressive symptoms in substance abuse treatment. Arch Gen Psychiatry. 2011 Jun;68(6):577-84. doi: 10.1001/archgenpsychiatry.2011.53. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
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| Secondary | Mental Health Functioning as Measured by SF-12 MCS. | The SF-12 is a 12 question, self-administered measure of general health functioning. The SF-12 outputs a mental health summary score (MCS), which ranges from 0 to 100, with higher scores indicating better mental health functioning. MCS scores are standardized such that mean = 50 and SD = 10 in the general U.S. population. | Posted | Mean | Standard Deviation | SF-12 score | 3 Months Post Treatment |
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| 0 |
| 140 |
| 0 |
| 140 |
| EG001 | Comparison | Treatment as Usual comparison condition | 0 | 159 | 0 | 159 |
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